LearningPlus Solutions: Workshop: FDA and GMP Update for 2006/2007

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FDA and GMP Update for 2006/2007

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	Overview		A look at recent trends and issues related to the FDA and the cGMPs. Topics covered are selected based on needs of the firm and the industry/regulatory issues that are "hot" at the time.
	Objectives		Describe events that are shaping regulatory agencies and the pharma industry's compliance-related activities Describe trends in FDA-issued warning letters and FDA-483s as well as industry recalls Identify proposed changes to GMPs in the US, Canada, and Europe Given a case, identify the consequences of not following GMP
	Instructional Methods		Presentation, case study, and discussion.
	Primary Audience		Technical, supervisory, and management personnel.
	Length		2 - 4 hours.